Our biotechnology regulation experience includes:
- Representing clients in product reviews, whether initiated by the government, competitors, or activist groups.
- Representing clients in court actions to challenge government activities that are inconsistent with the law, to defend the validity of approvals issued over competitor or public interest group objections, and to resolve commercial disputes with other private parties.
- Helping clients to meet federal and state requirements for obtaining approvals, and advising them on the full range of compliance issues, including labeling (and its potential impact on product liability); import and export restrictions; permissible supply, manufacturing, and marketing relationships; and allowable label and marketing claims.
- Providing transactional assistance to clients who wish to acquire or sell some or all of a biotechnology business.
- Representing clients in key fora around the world on the negotiation and implementation of international agreements impacting the biotechnology industry and related product sectors.
- Representing clients who wish to prevent or minimize the legal risks associated with investing in biotechnology in key developing countries around the world and who wish to better understand the effects on the biotechnology industry and related product sectors of the rapidly developing “biosafety” and “organic food” legal regimes in such countries.
Our pesticides regulation experience includes
- Representing clients in health or environmental reviews of their pesticides, whether initiated by the federal government, state authorities, competitors, or activist groups.
- Working with clients to develop comprehensive strategies for defending their products; evaluating product risks and benefits; developing risk reduction proposals and negotiating agreements to address risk concerns while keeping products on the market; and, if necessary, representing registrants in hearings to oppose use restrictions or cancellations.
- Assisting clients in protecting valuable research data rights, including ensuring that competitors satisfy applicable data requirements, comply with their obligations to pay compensation for relying on our clients’ data to obtain follow-on registrations, and do not gain access to data that are entitled to exclusive use.
- Advising on worldwide data rights protection and represent clients in compensation negotiations, regulatory agency petition proceedings, and arbitrations mandated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), and by similar state and international laws as well as in related lawsuits in state and federal courts, collaborating with practitioners in other countries where such legal actions are necessary.
- Representing clients in court actions to challenge government activities that are inconsistent with the law; defending the validity of registrations, permits, and deregulations issued over competitor or public interest group objections; and resolving commercial disputes.
- Representing companies and task forces (some involving dozens of companies) required to meet data requirements, including negotiations with government officials over the scope of data requirements and with other applicants and registrants regarding data development and sharing costs.
- Assisting clients in meeting federal and state requirements for pesticide registrations and related seed permits or deregulations and advising on the full range of compliance issues, including label language (and its potential impact on product liability); import and export restrictions; supply, manufacturing, licensing, and marketing relationships and contracts for both pesticides and related seed matters; and allowable label and marketing claims for both agricultural and consumer products, including antimicrobial claims.
- Counseling and assist clients who want to acquire or sell some or all of a pesticide or seed business, its registrations or permits, and data rights.
- Defending clients in enforcement actions, including settlement agreement negotiations that protect their business objectives.